A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants

Shanghai Huaota Biopharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: HB0043

Study type: Interventional

Funder types: Industry

Identifiers

NCT06999083

HB0043-HV-01-01

Details and patient eligibility

About

The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.

Full description

This is a single-dose escalation study of HB0043 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0043.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must meet the following criteria to be eligible for study entry:

  1. Healthy male or female subjects age ≥ 18 and ≤ 55 years.
  2. Men and women of reproductive potential, willing to practice a highly effective method of birth control for the duration of the study and continuing for 6 months after receiving the last dose of drug administration. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom (men) in combination with other barrier methods, hormonal birth control or IUD (women).
  3. Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
  4. No clinically significant findings in the medical history and physical examination.
  5. No clinically significant laboratory values (including urinalysis), unless the investigator considers any abnormality to not be clinically significant.
  6. Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the investigator considers any abnormality to be not clinically significant.
  7. Informed consent must be obtained for all subjects enrolled into the study.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from study entry:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease.

2. Current or history of malignancy.

3. Family history of premature Coronary Heart Disease (CHD).

4. Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Exposure to any prescription medication 14 days prior to randomization, to herbal remedies or over-the countermedications (except for the occasional use of acetaminophen [up to 2,000 mg per day]) 7 days prior to randomization.

5. Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.

6. Known allergy to biologics.

7. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing

8. Had a vaccination with a live attenuated vaccine within 1 months prior to dosing.

9. Subjects at risk for tuberculosis (TB), specifically subjects with:

   • Current clinical, radiographic or laboratorial evidence of active TB;
   • Positive interferon-γ release assay (IGRA) test.

10. Positive test at screening for any of the following infectious disease tests: Hepatitis B, surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), Human immunodeficiency virus antibody (HIV Ab).

11. History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).

12. A helminth parasitic infection diagnosed within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy.

13. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.

14. Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing.

15. History of drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening, or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening. Positive drug screen (cocaine, methamphetamine, phencyclidine, and Tetrahydrocannabinol) at screening or Day -1.

16. History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening. Positive Breath Alcohol Test at screening or Day -1.

17. Current cigarette smoker (cigarettes or e-cigarettes) who smoke over 5 cigarettes/day within 3 months prior to screening.

18. Mental condition rendering the subject incapable of understanding the nature, scope, and possible consequences of the study.

19. Pregnant or Breasting feeding subject. Women with positive pregnancy test (hCG). Or subjects who plan to donate sperms or eggs, from dosing until at least 6 months after last dose of investigational medicine.

20. Adults under guardianship and people with restriction of freedom by administrative and legal decisions.

21. Unlikely to comply with the clinical study protocol, e.g. uncooperative attitude, inability to return for followed-up visit, and improbability of completing the study.

22. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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52 participants in 7 patient groups, including a placebo group

HB0043 dose group 1

Active Comparator group

Description:

HB0043 single dose

Treatment:

Drug: HB0043

HB0043 dose group 2

Active Comparator group

Description:

HB0043 single dose

Treatment:

Drug: HB0043

HB0043 dose group 3

Active Comparator group

Description:

HB0043 single dose

Treatment:

Drug: HB0043

HB0043 dose group 4

Active Comparator group

Description:

HB0043 single dose

Treatment:

Drug: HB0043

HB0043 dose group 5

Active Comparator group

Description:

HB0043 single dose

Treatment:

Drug: HB0043

HB0043 dose group 6

Active Comparator group

Description:

HB0043 single dose

Treatment:

Drug: HB0043

Matching placebo for each dose group

Placebo Comparator group

Description:

placebo, single dose

Treatment:

Drug: Placebo